The Angioma's Treatment Evaluation With Laser Doppler Imaging (LDI)

NCT ID: NCT01759082

Last Updated: 2013-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-10-31

Brief Summary

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Based on the Doppler effect, Laser Doppler Imaging (LDI) uses the interaction of light with moving erythrocytes to visualize perfusion in the microcirculatory system.

The new device to be used in this study have been adapted specifically for the application, facilitating its use in clinic. It has been designed to take a standard white light image of the area under inspection simultaneously with the perfusion image to facilitate clinical assessment.

Port-wine stain (PWS) birthmarks are congenital, low-flow vascular malformations of the skin found in approximately 0.3% of children. They are commonly found on the face and neck and may cause serious psychological consequences.

Lasers are the modality of choice for the treatment of PWS birthmarks. The use of PDL is very effective in PWS in closing the blood vessels and diminishing therefore the redness of the skin. Repeated laser treatment is necessary to achieve the desired clinical outcome.

Actually, the efficacy of the treatment of PWS by the laser is obtained by clinical inspection and digital photography.

By measuring the activity and intensity of the microcirculation present in and under the skin, the Laser-Doppler (LDI) will be capable of measuring the effect of Pulsed dye laser (PDL) treatment for port-wine stains.

Detailed Description

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Conditions

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Port-wine Stains (PWS)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* children aged 12 months to 6 years old
* port-wine stains (PWS)
* phototype's skin I, II or III

Exclusion Criteria

* phototype's skin IV, V or VI
* prior treatment with laser
* contraindication of general anesthesia
* refusal from the parents
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Tessa Mermod

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony DeBuys Roessingh, Dr MD PhD

Role: PRINCIPAL_INVESTIGATOR

Paediatrics Surgery

Other Identifiers

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CHP

Identifier Type: -

Identifier Source: org_study_id

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